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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174006
Device Problems Physical Resistance (2578); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2017
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter: occurred during a laparoscopic inguinal hernia procedure. The tacking device was being applied to the cooper's ligament. Tacks were able to be fired normally from the device. The fired tacks were able to penetrate the tissue and hold correctly onto the tissue. The handle was stuck after a few shots. No tacks were able to be fired after the handle stuck. There was no patient injury.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the product noted a tack was protruding from the tip of the device and the trigger was jammed. The trigger was actuated after disassembling the body from the tube. Tacks were jammed in the tube and did not deploy. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the reported condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface. If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

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Brand NamePROTACK
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer (Section G)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key7135218
MDR Text Key95731459
Report Number2647580-2017-08999
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeIS
PMA/PMN NumberK090470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174006
Device Catalogue Number174006
Device LOT NumberP7A1552PX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/31/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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